Regulatory: Page 134

Elekta gets Japanese nod for Agility
By AuntMinnie.com staff writers
Radiation oncology firm Elekta has received clearance from the Japan Pharmaceuticals and Medical Devices Agency for its Agility multileaf collimator.
July 30, 2012
Agfa debuts CR 10-X in North America
By AuntMinnie.com staff writers
Agfa HealthCare has received U.S. Food and Drug Administration 510(k) clearance for its CR 10-X tabletop digitizer, which is now available across North America.
July 30, 2012
Report: CMS cuts threaten brachytherapy growth
By AuntMinnie.com staff writers
A proposal by the U.S. Centers for Medicare and Medicaid Services (CMS) to impose a 19% reimbursement cut for radiation oncology in its Medicare Physician Fee Schedule (MPFS) for 2013 could negatively affect growth in the radiation therapy market by 6% in 2012 and 10% in 2013, according to a new report by market research group GlobalData.
July 29, 2012
FDA extends Bracco's MultiHance use
By AuntMinnie.com staff writers
Contrast agent developer Bracco has received word that the U.S. Food and Drug Administration has approved an expanded use for the company's MultiHance MR contrast agent.
July 29, 2012
NH to expand hepatitis C testing
By AuntMinnie.com staff writers
State health authorities in New Hampshire are extending a hepatitis C testing program in the wake of revelations that a traveling cardiac cath lab technologist may have infected patients with the disease after allegedly diverting fentanyl from the lab for his own use.
July 24, 2012
Cardiac cath technologist charged in hepatitis C infections
By Kate Madden Yee
Federal authorities in New Hampshire have charged a traveling cardiac cath technologist with infecting patients with hepatitis C after he allegedly stole syringes containing fentanyl and replaced the dirty needles with saline solution. The case has authorities fearing an outbreak of hepatitis C in more than half a dozen states.
July 23, 2012
Siemens gets FDA nod for Spectra
By AuntMinnie.com staff writers
Siemens Healthcare has received U.S. Food and Drug Administration clearance for its Magnetom Spectra 3-tesla MR scanner.
July 23, 2012
Calif. center named to medical device committee
By AuntMinnie.com staff writers
The Medical Diagnostic Equipment Accessibility Standards Committee has named the Harris Family Center for Disability and Health Policy at Western University of Health Sciences in Pomona, CA, as a new member.
July 23, 2012
CMS takes feedback to modify PET agent review process
By Wayne Forrest
Agreeing to a request from five medical imaging organizations, the U.S. Centers for Medicare and Medicaid Services (CMS) has begun taking public comment on a proposal to streamline the process by which PET imaging agents are reviewed and approved for reimbursement.
July 22, 2012
HIT certification bodies and test labs accredited
By AuntMinnie.com staff writers
The American National Standards Institute has completed its first round of accreditations for certification bodies, which can apply to the Office of the National Coordinator (ONC) for authorization to certify electronic health record technologies in the ONC Permanent Certification Program.
July 19, 2012
GE's cardiac CT platform nets FDA clearance
By AuntMinnie.com staff writers
GE Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for its new cardiac imaging platform, the Discovery CT750 HD Freedom Edition.
July 18, 2012
Crux gets FDA nod for inferior vena cava filter
By AuntMinnie.com staff writers
Crux Biomedical has received U.S. Food and Drug Administration (FDA) clearance for its inferior vena cava filter with bidirectional retrieval.
July 18, 2012
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